What do you do when standing in line at Starbucks? ... why check your clinical data against CDISC standards :) http://bit.ly/7pVze
Posts
CDISC Verification on iPhone
CDISC guidelines helps clinical data comply to a standard intended for submission to the FDA so it is important to ensure that you comply with all the guidelines. If you were to review the CDISC guidelines , you will see hundred of pages of rules which your data must comply with. To do this review manually would be time consuming and most likely lead to errors due to not being able to catching the details. The part that I find challenging about reviewing data against CDISC has to do it multiple times as data is being developed. There are times when I need to review the latest update and I am not at my desk. I have found a solution for this when I am out and about, I can review the latest data on my iPhone. This allows me to see how standardize my data is and I see the status of my CDISC effort at any moment even standing in line at Starbucks. :) I capture a YouTube video as to how this is done which you can see below.
Performing Stability Analysis on iPhone
I was finishing up performing an analysis for a client developing a SAS macro to perform stability analysis. There are some good guidelines for this since the FDA has clearly defined how this is done. I found the article on the FDA website entitled " International Conference on Harmonization (ICH) - Guidance for Industry: Q1E Evaluation of Stability Data " to be very useful. Once I was able to get a SAS macro to perform this task, the next challenge is to have this available on an iPhone so the user can access the latest analysis anywhere on their iPhone. Rather than going into a verbose description here, I recorded a video to illustrate this to you. I find that the iPhone which is a multi-touch graphical user interface can be best explained by showing so hope you find this video useful.
Does some one at Apple review every App sent to AppStore?
I recently submitted an iPhone application to the apple developer program to be approved. This was my first time so the hoops that Apple had me jump through were interesting. The initial application had general information which seems pretty normal. These included things such as: Application Name: BI Flash Application Description: BI Flash delivers business intelligence to information to the iPhone. It takes SAS macros, programs or data on a server and delivers this to iPhone. The user can register the programs or SAS libraries, and then make this available to specified users who can then view this through BI Flash on the iPhone. This is executed in real time so the user gets always the latest data. Primary Category: Business Keywords: Business Intelligence, SAS, Analytics Application URL: http://meta-x.com/biflash These seem pretty standard since they would probably use this for the AppStore. The next step is pretty interesting since it asked for me to check three categories i...
Validating Transformation to CDISC SDTM and ADaM
You have just finished transforming your data from your operational clinical database into SDTM and ADaM, now how do you go about validating this? In general you want to have a method that reviews both the structure according to the guidelines and the values of the data to ensure that nothing is changed from what was collected. The following steps uses SAS tools to validate and ensure the integrity of your final CDISC data. Transformation Model Validation- A transformation model documenting the source data and how it was transformed confirming the destination and source variables. Data Value Subset Review - An automated report printing out a subset of the data before and after the transformation is reviewed and validated. This may catch truncation. Categorical Aggregate Review - An automated summary report is generated summarizing the frequency counts of categorical variables verifying the counts are the same. This...
Video Interviews at WUSS 09 Conference
New media has made it possible for a non professional like me to become a reporter. I did an experiment at a recent conference in San Jose. I took my Canon Elph which is normally used for taking pictures and switch on its video mode. It is so small that members that I interviewed barely noticed it was there. I then talked to the attendees at the conference in their area of expertise similar to what I use to do in the traditional blogging days where I would write up the blog based on the interview. The difference this time is upon completion of the interview, I would upload the videos directly to YouTube and whoa.. la... there it was. I did not edit it or do anything. I realize that while holding the camera on my hand, it was not on a tripod so it was perhaps not stable and I was looking at the person I was talking to so the composition was not optimal but this adds to the whole amateur video blogging experience. This experiment of one man on the fly reporting was interesting. I...